DIALGUARD ENDOTOXIN REMOVAL DEVICE— 510(k) K993806

Name: FDA 510(k) clearance K993806
Creator: U.S. Food and Drug Administration
Published: 2000-08-14

Substantially Equivalent

Clarigen, Inc.

FDA 510(k) clearance K993806 for DIALGUARD ENDOTOXIN REMOVAL DEVICE, Substantially Equivalent on 2000-08-14. Applicant: Clarigen, Inc.. Device class: 2.

Clearance details

Applicant: Clarigen, Inc.
Product code: Code FIP
Device class: Class 2
Regulation: 21 CFR 876.5665
Advisory panel: Gastroenterology, Urology
Date received: 1999-11-09
Decision date: 2000-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FIP

product code FIP

Malfunction: 490
Total: 490

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.